A group that has been formally designated to review and monitor research involving human subjects., IBC, FDA, IRB, NIH, A legally binding agreement that manages the relationship between the sponsor that may be providing the study drug or device, the financial support and /or proprietary information and the institution that may be providing data and/or results, publication and input into further intellectual property., Protocol, Amendment, Clinical Trial Agreement, DOA Log, A document that describes how the clinical trial will be conducted., Informed Consent Form, Protocol, Delegation of Authority Log, Clinical Trial Agreement, Documents required learning for each study member before they start any research tasks. This is required for each person before any research tasks are completed., Financial Disclosure Form, Training Log, Protocol, Contract, A document that provides participants with the information they need to make a decision regarding study involvement., Informed Consent Form, Protocol, Investigator’s Brochure, Curriculum Vitae, A document that provides participants under the age of 18 years old with the information they need to make a decision regarding study involvement., Assent, Financial Disclosure Form, Parental Permission Consent, Investigator’s Brochure, A group responsible for reviewing projects that involve recombinant DNA, RNAi, pathogens, human materials and other potentially infectious material., IBC, FDA, NIH, IRB, A list of duties and responsibilities that have been delegated to each study staff member by the PI., Clinical Trial Agreement, DOA Log, Adverse Event, Contract, A document that communicates financial relationships of a study staff member., Clinical Trial Agreement, Financial Disclosure Form, Parental Permission Consent, DOA Log, Updated study information, which may include the protocol, IB, or recruitment materials, that must be approved by the IRB before it can be implemented., Investigator’s Brochure, Adverse Event, Amendment, Clinical Trial Agreement, The individual or organization that funds the trial and sets the protocol. , Study Site, Sponsor, FDA, NIH, Events that are different from the patient's documented baseline health history. , Clinical Trial Agreement, Training, Adverse Event, Amendment, A comprehensive document with complete information of clinical and nonclinical data on the investigational drug., Contract, Adverse Event, Monitor, Investigator’s Brochure.

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